Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George Theodoropoulos, University of Athens
ClinicalTrials.gov Identifier:
NCT01479907
First received: November 16, 2011
Last updated: May 11, 2016
Last verified: May 2016
  Purpose

The aim of this double-blinded prospective randomised trial is to explore the potential benefits of early postoperative administration of Synbiotics (combination of prebiotics and probiotics) to patients who have undergone colectomy for cancer. The patients are randomised to either synbiotics or placebo administration at the day they are able to tolerate po liquid diet and for 15 days thereafter.

Primary end points of the study will be:

Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of Life Index)

Secondary end points will be:

-Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30


Condition Intervention
Colorectal Neoplasms
Dietary Supplement: Synbiotics
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2010
Study Completion Date: September 2015
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Synbiotics
A specific multistrain/multifi ber synbiotic composition of prebiotics and probiotics (Synbiotic Forte™, "IONIA" Pharmaceuticals, Athens, Greece) was administered at the active comparator arm of the study. It contained 10 [11] of each of four lactic acid bacteria (LAB): Pediococcus pentosaceus 5-33:3, Leuconostoc mesenteroides 32-77:1, Lactobacillus paracasei ssp. paracasei 19, and Lactobacillus plantarum 2362, and 2.5 g of each of the four fermentable fibers (prebiotics): b-glucan, inulin, pectin and resistant starch. The synbiotics were delivered in sachets and then mixed with water (12 g in 250 mLof water once daily). Th e treatment started on the day patients tolerated per os liquid intake (2nd-4th POD). The intervention period lasted 15 days.
Dietary Supplement: Synbiotics
12 gr in 250 cc of water once daily X 15 days
Placebo Comparator: Placebo
The patients belonging to the placebo comparator arm received only the 4 fi bers and no LAB (12 gin 250 mLof water once daily for 15 days). All the subjects were interviewed by a dedicated research fellow (KP) and reactions to the product, and any adverse events occurring in the 15-day period were recorded.
Dietary Supplement: Placebo
12 gr in 250 cc of water once daily X 15 days

Detailed Description:
The study patients are randomized before surgery to receive either synbiotics (Synbiotics group) or placebo (Control group). Equal randomization is accomplished using a computer-generated random allocation schedule. The method of allocation concealment is sequentially numbered sealed opaque envelopes technique. Both synbiotics and placebo preparations are in foil-sealed sachets stored in identical numbered containers. Both study products are white powders, identical in weight, smell, and taste. Thus, the identity of the specific product is blind to participants, support staff and investigators for the entire duration of the study period.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colectomy for histologically proven colorectal adenocarcinoma

Exclusion Criteria:

  • Pregnancy,
  • hereditary cancer,
  • history of inflammatory bowel disease,
  • metastatic disease at presentation,
  • emergency operation,
  • major postoperative complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479907

Locations
Greece
First Department of Propaedeutic Surgery of Athens Medical School, Hippocration General Hospital
Athens, Greece, 11527
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: George E Theodoropoulos University of Athens
  More Information

Responsible Party: George Theodoropoulos, Ass Professor of Surgery, Athens Medical School, University of Athens
ClinicalTrials.gov Identifier: NCT01479907     History of Changes
Other Study ID Numbers: SYNBIOTICSCOLON 
Study First Received: November 16, 2011
Last Updated: May 11, 2016
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on May 26, 2016